None listed
Conditions
Brief summary
This feasibility study aims to explore whether the withdrawal of Continuous Positive Airway Pressure (CPAP) therapy affects markers of brain health (such as oxidative stress) and/or memory over a 14-day period. The study will also identify the time point at which CPAP withdrawal has the greatest effect on markers of brain health to facilitate planning for a larger randomized controlled trial. We hypothesize that CPAP withdrawal will result in an increase in oxidative stress in treatment compliant OSA patients. Furthermore, we also hypothesize that increases in oxidative stress will be negatively associated with sleep dependent memory consolidation and greater affective symptom severity over time.
Interventions
Following initial screening, and after obtaining informed consent, potential participants will be invited to complete a 4-day trial of CPAP withdrawal to confirm eligibility. Participants will then return to treatment as usual for a minimum of 2-weeks before taking further part in the trial.
Participants will then attend the Healthy Brain Ageing (HBA) Research Clinic at the Brain and Mind Centre (BMC) to complete baseline characterization of their cognition, quality of life, physical health sta
Following initial screening, and after obtaining informed consent, potential participants will be invited to complete a 4-day trial of CPAP withdrawal to confirm eligibility. Participants will then return to treatment as usual for a minimum of 2-weeks before taking further part in the trial. Participants will then attend the Healthy Brain Ageing (HBA) Research Clinic at the Brain and Mind Centre (BMC) to complete baseline characterization of their cognition, quality of life, physical health status, mood and other descriptives. A baseline MRI scan and measure of arterial stiffness will also be conducted at this time. After completing the baseline assessment, participants will stay overnight at the Woolcock Institute of Medical Research (WIMR) completing memory consolidation tasks in the 1 hour prior to habitual sleep onset, and 1 hour after waking. Pre- and post-sleep MRI scans will be collected at follow-up assessments, along with measures of overnight memory consolidation and arterial stiffness. Participants will remain on treatment as usual for the first 7-days, followed by CPAP withdrawal for 14-days. All assessments and oversight of the intervention will be conducted by researchers at the WIMR. A summary of the time commitment required for participation and the study procedure is provided below: • Days -18 to -14: Eligibility screening followed by 4-day CPAP withdrawal eligibility confirmation • Days -14 to 0: 2-week washout period – Treatment as usual • Day 0: Baseline assessment – Treatment as usual • Day 7: Follow-up 1 – CPAP therapy withdrawal • Day 14: Follow-up 2 – continued CPAP therapy withdrawal • Day 21: Follow-up 3 – End of trial; Participant returned to treatment as usual CPAP withdrawal will involve participants complete cessation of the use of their CPAP treatment. Compliance during the treatment as usual phase and the CPAP withdrawal phase will be monitored via data computed by and downloaded directly from the participant's CPAP device. Participants will also complete a sleep diary during the CPAP withdrawal phase. Treatment as usual is as per the participant's individual prescription from their sleep technician at the time of obstructive sleep apnoea diagnosis.
Sponsors
The Woolcock Institute of Medical Research, University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Be greater than 50 years old at time of assessment. • Be fluent in English. • Have been previously diagnosed with OSA. • Be currently undertaking CPAP therapy for more than 3 months with good compliance. • Be willing to attend appointments at both the Woolcock Institute of Medical Research and Brain and Mind Centre.
Exclusion criteria
• Have a suspected dementia or amnestic MCI on Telephone interview for the Cognitive Status score of <31 • Have a history of stroke or other neurological disorder • Have a current neurological or psychiatric condition (e.g. schizophrenia) • History of cardiac atrial fibrillation • Have an intellectual disability • Have a current affective disorder (e.g. depression, anxiety) • Are a shift-worker • Have current or future plans for trans-meridian travel during the trial period • Are currently taking any medications known to affect sleep • Have any contraindications for MRI scanning (e.g. pacemaker) • Do no demonstrate OSA symptom relapse (specifically apnoeas/hypoapnoeas)
Outcome results
None listed